Explore the essentials of food law and regulation and gain a comprehensive understanding of the various administrative agencies that impact these industries. Learn about pending regulations, food safety, food labeling, enforcement, and related issues. Case studies, hypotheticals, and ample time for discussion are provided.
Agenda Highlights
- Organizational structure of the FDA
- Concepts and statutes in food law and regulation, and the relationship between state and federal jurisdiction
- Principles of food labeling requirements and litigation risks as shaped by FDA, the Federal Trade Commission (FTC), and class action litigation
- Role of inspection and enforcement authorities and practical steps toward compliance
- Food safety frameworks, including review of Food Safety Modernization Act (FSMA) final rules and guidance for industry
- International issues that affect food law and regulation in the United States
- Dietary supplement oversight and the regulation of cosmetics
Statutes Covered
- Federal Food, Drug & Cosmetic Act (FD&C Act)
- Federal Meat, Poultry, and Egg Products Inspections
- Federal Trade Commission 15 U.S. C. § 41 et. seq.
- Lanham Act – 15 U.S.C. §1051 et seq.
Attendee Resources
These valuable takeaways will be provided:
- Speaker handouts and related reference materials
- Access to an electronic copy of the FDCA Statutory Supplement, 2021 2nd Edition
Who Should Attend
- New legal and regulatory professionals
- Seasoned practitioners new to the topic or wanting a refresher
Register
Industry & Firms
- +$250 for non-members
Non-Profit
- +$100 for non-members
Government
- +$100 for non-members
Academic
- +$100 for non-members
Add This Must-Have Reference to Your Registration
Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.
Agenda
subject to change
All times are in Eastern Daylight Time
Curriculum Advisor: Ann M. Begley, Partner, Wiley LLP
Tuesday, September 21
12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
12:05–1:05 PM
Overview of U.S. Food Law and Regulation
T. Daniel Logan, Associate, Kleinfeld, Kaplan & Becker, LLP
1:05–1:15 PM
Break
1:15–2:20 PM
Food Safety: Ingredient Preclearance/Intentional Components of Food
Natalie Rainer, Partner, Keller and Heckman LLP
2:20–2:35 PM
Break
2:35–3:50 PM
Food Safety: Current Good Manufacturing Practices and Related Requirements; Unintended Components/Contaminants of Food
Charles M. Breen, IndependentConsultant, EAS Consulting Group
3:50–4:00 PM
Break
4:00–5:00 PM
U.S. Department of Agriculture
Brian Sylvester, Special Counsel, Covington & Burling LLP
Wednesday, September 22
12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
12:05–1:05 PM
Food Derived from Biotechnology – the USDA/FDA Conundrum
Ann M. Begley, Partner, Wiley LLP
1:05–1:15 PM
Break
1:15–2:25 PM
Food Labeling: General Requirements (Including Meat and Poultry)
Steven Armstrong, Senior Regulatory Advisor, Haynes and Boone LLP
2:25–2:35 PM
Break
2:35–3:45 PM
Food Labeling: Nutrient Content, Health and Other Claims
Todd A. Harrison, Partner, Venable LLP
3:45–3:55 PM
Break
3:55–5:00 PM
Advertising: The Federal Trade Commission and Private Rights of Action
Cynthia L. Meyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Thursday, September 23
12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
12:05–1:20 PM
Dietary Supplements
Megan Olsen, Vice President & Associate General Counsel, Council for Responsible Nutrition
1:05 – 1:15 PM
Break
1:15 – 2:15 PM
The Regulation of Cosmetics
Raqiyyah Pippins, LifeSciences and Healthcare Regulatory Partner, Arnold & Porter LLP
2:15–2:30 PM
Break
2:30–3:45 PM
Inspection and Enforcement Authority
Brigid Bondoc, Of Counsel, Morrison and Forester, LLP
3:45–4:00 PM
Break
4:00 – 5:00 PM
Imports and International Issues
John F. Johnson, III, Of Counsel, Shook, Hardy & Bacon LLP
5:00 PM
Adjournment
Continuing Legal Education
FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.